跳至主要内容
临床试验/NCT04281693
NCT04281693Unknown不适用

Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection

Affiliated Hospital to Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2020年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
230
试验地点
1
主要终点
Screening accuracy

研究概览

简要总结

Since Dec 2019, over 70000 novel coronavirus infection pneumonia (NCIP) patients were confirmed. 2019 novel coronavirus (2019 nCoV) is a RNA virus, which spread mainly from person-to-person contact. Most of the symptoms are non-specific, including fever, fatigue, dry cough. Sever NCIP patients may have shortness of breath and dyspnea, and progress to acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS). The mortality is reported to be around 2.3%. Thus, early detection and early treatment is very important to the improvement of NCIP patients' prognosis. At present, NCIP RNA detection of pharyngeal swab specimen by RT-PCR is recommended. However, due to the universal susceptibility to 2019 nCoV in general population and limited number of NCIP RNA detection kits available, to identify an efficient screening strategy is urgently needed. This study aim to develop and validate the diagnostic accuracy and screening efficiency of a new NCIP screening strategy, which can benefit the disease prevention and control.

详细描述

This clinical trial is designed to compare the screen accuracy and efficiency of two screening strategies. Considering that the general population is susceptible to 2019 nCoV, a great number of people need to be screened for NCIP. The new screening strategy of minipool testing may not only obtain a comparable accuracy to the standard individual testing, but also save time and money, which may benefit the current clinical practice.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Who agree to participate in the study and sign written informed consent

排除标准

  • •Confirmed NCIP patients

研究组 & 干预措施

Screening participants

Experimental

干预措施: Standard screening strategy (Diagnostic Test)

Screening participants

Experimental

干预措施: New screening strategy (Diagnostic Test)

结局指标

主要结局

Screening accuracy

时间窗: 1 month

The screening accuracy of the two screening strategies were calculated and compared.

次要结局

  • Cost-effectiveness analysis(1 month)

研究者

发起方
Affiliated Hospital to Academy of Military Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验